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Dear All
This question is with regards to FDA registered medical devices in the US.
What are the requirements before an exempted Class I medical device is approved to be marketed in the US?
Are FDA approval letters issued for exempted Class I medical devices?
Many thanks in advance for the insights to the above questions.
Thanks & Regards
Pyrules
This question is with regards to FDA registered medical devices in the US.
What are the requirements before an exempted Class I medical device is approved to be marketed in the US?
Are FDA approval letters issued for exempted Class I medical devices?
Many thanks in advance for the insights to the above questions.
Thanks & Regards
Pyrules